External drug pump

ABSTRACT

Apparatus is described for administering a substance to a subject. A vial contains the substance and a stopper is disposed within the vial and is slidably coupled to the vial. A first threaded element is (a) rotatable with respect to the vial and (b) substantially immobile proximally with respect to the vial during rotation of the first threaded element. A second threaded element is threadedly coupled to the first threaded element. At least a distal end of the second threaded element is substantially non-rotatable with respect to the vial, and the distal end of the second threaded element defines a coupling portion that couples the second threaded element to the stopper. The first threaded element, by rotating, linearly advances the stopper and at least the distal end of the second threaded element toward a distal end of the vial. Other embodiments are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/593,051, filed on Jan. 9, 2015, entitled “External Drug Pump,” whichis a continuation of similarly-titled U.S. patent application Ser. No.12/244,666, filed on Oct. 2, 2008 and issued on Nov. 3, 2015 as U.S.Pat. No. 9,173,997, which claims the benefit of similarly-titled U.S.Provisional Patent Application No. 60/997,459, filed on Oct. 2, 2007,the contents of each of which are incorporated by reference herein intheir entirety.

The present application is related to U.S. patent application Ser. No.12/244,688, filed on Oct. 2, 2008, entitled “External Drug Pump,” thecontents of which are incorporated by reference herein. The applicationis also related to International Patent Application No.PCT/IL2008/001312, filed on Oct. 2, 2008, entitled “External Drug Pump,”the contents of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention generally relates to external medical apparatus.Specifically, the present invention relates to external drug pumps.

External drug pumps are typically used to deliver to patients substanceswhich contain large molecules which cannot be digested when administeredorally. They are commonly used to infuse a basal rate of insulin tosubjects suffering from diabetes, as an alternative to insulininjections by an insulin syringe or an insulin pen. Typically, the pumpis adhered to the abdomen of the patient and delivers the substance tothe patient via a cannula that is inserted into the patient's skin.

U.S. Pat. No. 6,656,159 to Flaherty, describes a device for deliveringfluid, such as insulin for example, to a patient. The device includes anexit port assembly, a syringe-like reservoir including a side wallextending towards an outlet connected to the exit port assembly. Athreaded lead screw is received in the reservoir and a plunger has anouter periphery linearly slideable along the side wall of the reservoirand an inner periphery threadedly received on the lead screw. Theplunger is non-rotatable with respect to the side wall such thatrotating the lead screw is described as causing the plunger to advancewithin the reservoir and force fluid through the outlet. The device alsoincludes a dispenser having a return element for causing rotation of thelead screw, and a shape memory element. A changeable length of the shapememory element decreasing from an uncharged length to a charged lengthis described as resetting the return element.

U.S. Pat. No. 6,699,218 to Flaherty, describes a device for deliveringfluid to a patient, including a passageway having a proximal fluidtransport tube, a distal fluid transport tube, and a tubular expansionmember coupling the fluid transport tubes. A penetrating member ispositioned within the expansion member for axial movement between thefluid transport tubes, and has a sharpened distal tip. The device alsoincludes a dispenser for causing fluid from a reservoir to flow to theproximal fluid transport tube, a housing containing the dispenser andthe passageway and including an exit port receiving the distal fluidtransport tube, and a connecting member secured to the penetratingmember. The connecting member is movable by a user from an exterior ofthe housing and arranged such that movement causes the penetratingmember to move between an extended position for subcutaneously insertingthe distal fluid transport tube into a patient, and a retractedposition.

U.S. Pat. No. 6,485,461 to Mason, describes a disposable device which isdescribed as accurately and reliably delivering an infusable liquid to apatient. The infusion device includes a housing which defines a bladderchamber. A compressible bladder is disposed in the bladder chamber andis compressed by the housing upon filling the bladder with an infusableliquid to create a pressurized bladder. The infusion devices furtherincludes a delivery system for subcutaneously delivering the infusableliquid to a body. The delivery system includes a collapsible member thatsupports an injection needle and a cannula. The injection needle is usedto insert the cannula into the skin of the body being treated. Thecannula is in communication with the bladder during delivery of theinfusable liquid. The housing includes microfluidic passageways thatallow communication between fluid in the bladder and the cannula.

U.S. Pat. No. 5,851,197 to Marano, describes an injector for automaticplacement of a subcutaneous infusion set or the like used for deliveringa selected medication to a patient. The injector comprises aspring-loaded plunger having a head for receiving and supporting aninfusion set in a position for placement of an insertion needle andrelated cannula through the skin of a patient at a selected insertionsite. The plunger head includes a safety lock mechanism described asengaging and retaining the infusion set during spring-loaded advancementwith a controlled force and speed toward the patient's skin totranscutaneously place the insertion needle and cannula. When theplunger head reaches a fully advanced position, with the infusion setplaced on the patient, the infusion set is releasable from the safetylock mechanism with minimal force to permit quick and easy separation ofthe injector.

U.S. Pat. No. 6,960,192 to Flaherty, describes a device for deliveringfluid to a person that includes a reservoir for containing a fluid to bedelivered to the person; a fluid transport device for dispensing fluidfrom the reservoir to the person, the fluid transport device including aproximal end in fluid communication with the reservoir and a distal endhaving a penetrating member for piercing the skin of the person tofacilitate the delivery of fluid to the person through the fluidtransport device; a housing containing the reservoir and the fluidtransport device, the housing including an exit port for receiving thedistal end of the fluid transport device upon injection of the distalend into the person and means for securing a first wall of the housingto the skin of the person; and an injection activation device includinga driving mechanism contacting the fluid transport device for drivingthe penetrating member from a first position within the housing, throughthe exit port to a second position, external to the housing and into theskin of the person.

U.S. Pat. No. 6,905,298 to Haring, describes a nut assembly that willensure that the shank of a bolt that features a measurable grip lengthwill pass through the contact plane of adjoining members. The nutassembly also allows the desired compressive force in the adjoiningmembers to be attained by using a telescopic feature of the nut toallocate additional thread action for the bolt, enabling the bolt to bedrawn into the nut further than what would be allowed by a standard nut.The adaptability of the nut assembly can eliminate the need for washersor shims to adjust the shank penetration of the bolt. The nut assemblyis useful for applications in which the specified thread length and thegrip length of the bolt is incompatible with the abutment thickness ofthe adjoining members.

U.S. Pat. No. 1,795,630 to Wilson, describes a screw jack that utilizesa series of telescopic screw threaded sections that may be compactlyarranged in the hollow base or housing of the jack when the jack is notin use, or when only a small space is available in which the jack is tobe used.

U.S. Pat. No. 5,643,218 to Lynn et al., describes a syringe for thesequential withdrawal of a first liquid and a second liquid. The syringehas a barrel, a proximal piston moveable along the barrel to define avariable volume chamber intermediate the piston and the end of thebarrel, and a distal chamber divider piston for separating the variablevolume chamber into primary and secondary reservoirs. A flow channel isdefined along the syringe for providing flow connection between theprimary and secondary reservoirs. An element links the two pistons sothat as the proximal piston is moved away from the distal piston, thefirst liquid enters the first reservoir and thereafter the second liquidenters the secondary reservoir.

Daikyo Crystal Zenith® polymer, manufactured by Daikyo Seiko, Ltd., andused by Daikyo Seiko, Ltd. to manufacture vials, is described as beingdurable, non-flaking, highly transparent, very low in extractable ions,compatible with a wide pH range, and resistant to high heat.

Copaxone® (glatiramer acetate), manufactured by Teva PharmaceuticalIndustries Ltd, is a drug described as helping patients who suffer fromrelapsing-remitting multiple sclerosis.

The following patent and patent application may be of interest:

-   -   U.S. Pat. No. 6,749,587 to Flaherty    -   U. S. Patent Application Publication 2007/0118405 to Campbell

BRIEF SUMMARY OF THE INVENTION

In some embodiments of the invention, a vial is provided that contains asubstance to be administered to a subject. The vial is sealed by astopper, and has therein first and second threaded elements (e.g., ascrew and a nut) that are threadedly coupled to each other. The firstthreaded element is rotatable with respect to the vial, and is linearlyimmobile with respect to the vial during rotation of the first threadedelement. The first threaded element, by rotating, is configured tolinearly advance the stopper and at least the distal end of the secondthreaded element toward the distal end of the vial, withoutsubstantially rotating the second threaded element and the stopper. Thedistal end of the second threaded element defines a coupling portionthat couples the second threaded element to the stopper.

In some embodiments, the stopper impedes rotation of the second threadedelement, for example, friction between the stopper and the inside of thevial impedes rotation of the second threaded element. Alternatively oradditionally, the vial is shaped such that the vial impedes rotation ofthe second threaded element.

For some applications, the threaded elements are used in conjunctionwith a standard, commercially-available vial and/or stopper.

Typically, the distal end of the first threaded element is configured toremain proximal to the stopper, or proximal to a distal end of thestopper, and the proximal end of the second threaded element isconfigured to remain proximal to the distal end of the stopper at alltimes during the rotating of the first threaded element.

Typically, the apparatus comprises a housing base, the vial and thethreaded elements being configured to be inserted into or otherwisecoupled to the housing base. For some applications, a portion of thehousing base is configured to automatically displace the threadedelements and the stopper toward a distal end of the vial during theinsertion into the housing base.

In some embodiments, the subject couples a housing top to the housingbase after the vial is inserted into the housing base. The housing toptypically contains a motor and a cog, the motor configured to rotate thecog and the cog configured to rotate the first threaded element. Forsome applications, a control unit administers a basal rate of thesubstance to the subject by controlling the motor. Alternatively oradditionally, the control unit is configured to receive an input and toadminister a bolus of the substance to the subject responsively to theinput. Further alternatively or additionally, the control unit controlsthe administering of the substance to the subject in response to thedetection by a sensor of one or more physiological parameters of thesubject.

For some applications, the substance is administered to the subject viaa cannula. Typically, the cannula surrounds a needle. The cannula isinserted into the subjects skin by piercing the subject's skin with theneedle and inserting the needle. The needle is typically retracted fromthe subject's skin following the piercing and the cannula remainsinserted in the subject's skin for the duration of the time that thesubstance is administered to the subject.

In some applications, the apparatus comprises a skin-piercing activationmechanism. Piercing the subject's skin comprises rapidly piercing thesubject's skin by displacing a force-receiving element of an activationmechanism. The application of a force to the activation mechanism thatexceeds a threshold force displaces the force-receiving element. Forexample, the subject may press a button coupled to the housing base ortop, and, upon application of force that exceeds the threshold force,the needle is suddenly released, and rapidly pierces the skin.

It is noted that the use of two separate portions, the housing top andthe housing base, facilitates easier sterilization of components thatshould be sterilized—particularly the tissue-contacting components ofthe housing base. The housing top, which typically comprises thebattery, motor, and associated electronics, is not typically sterilized.

Additionally, for added convenience of use by the subject, the housingtop may be easily removed prior to showering. Alternatively oradditionally, all of the components in the housing top are waterproof,such that the housing top may remain coupled to the housing bottom whilethe subject showers.

In some embodiments, the vial comprises (for example, the vial may becomposed of) a cyclic olefin polymer, such as Crystal Zenith®.

There is therefore provided, in accordance with an embodiment of thepresent invention, apparatus for administering a substance to a subject,including: a vial that contains the substance; a stopper within thevial, slidably coupled to the vial; a first threaded element (a)rotatable with respect to the vial and (b) substantially immobileproximally with respect to the vial during rotation of the firstthreaded element; and a second threaded element that is threadedlycoupled to the first threaded element, at least a distal end of thesecond threaded element substantially non-rotatable with respect to thevial, the distal end of the second threaded element defining a couplingportion that couples the second threaded element to the stopper, and thefirst threaded element, by rotating, linearly advancing the stopper andat least the distal end of the second threaded element toward a distalend of the vial.

In an embodiment, the apparatus further includes: a vial housing unitthat houses the vial and the threaded elements; a needle housing unitcoupled to the vial housing unit and not rigidly connected to thehousing unit; a needle housed within the needle housing unit; and acannula at least partially disposed around the needle, and the apparatusis configured to administer the substance to the subject via thecannula.

In an embodiment, the distal end of the second threaded element isdisposed at least partially within the stopper.

In an embodiment, the second threaded element is configured to becoupled to the stopper by a user.

In an embodiment, the second threaded element is provided to a user, thesecond threaded element already coupled to the stopper.

In an embodiment, the vial includes a circular barrel having an innersurface that is smooth.

In an embodiment, the substance includes insulin and the insulin isdisposed within the vial.

In an embodiment, a distal end of the first threaded element remainsproximal to a proximal end of the stopper at all times during therotating of the first threaded element.

In an embodiment, the apparatus further includes a dividing stopperwithin the vial, slidably coupled to the vial; the vial includes adistal compartment and a proximal compartment, the distal compartmentcontaining a powder and the proximal compartment containing a liquid,the dividing stopper reversibly inhibiting fluid communication betweenthe distal compartment and the proximal compartment, and the firstthreaded element, by rotating, mixes the powder and the liquid byadvancing the dividing stopper toward the distal end of the vial.

In an embodiment, a distal end of the second threaded element isconfigured to remain proximal to a distal end of the stopper at alltimes during the rotating of the first threaded element.

In an embodiment, the apparatus further includes a housing base, thevial and the first and second threaded elements are configured to beinserted into the housing base, and a portion of the housing base isconfigured to impede proximal linear motion of the first threadedelement during rotation of the first threaded element.

In an embodiment, the first threaded element includes thread thatdefines a maximal diameter and a pitch, and a ratio between the maximaldiameter and the pitch is 6:1 to 15:1.

In an embodiment, friction between the stopper and an inner surface ofthe vial impedes rotation of the second threaded element.

In an embodiment, friction between the stopper and an inner surface ofthe vial impedes rotation of the second threaded element while allowingdistal motion of the second threaded element.

In an embodiment, the apparatus further includes a housing base, thevial and the first and second threaded elements are configured to beinserted into the housing base, and a portion of the housing base isconfigured to displace the threaded elements and the stopper toward thedistal end of the vial during the insertion into the housing base.

In an embodiment, the portion of the housing base is configured to applya sufficient force, in displacing the threaded elements and the stopper,to overcome friction between the stopper and the vial that is due toprolonged storage of the stopper in contact with the vial.

In an embodiment, the apparatus further includes a cannula coupled tothe housing base and configured to be inserted into skin of the subject,and the housing base, by displacing the threaded elements and thestopper, is configured to expel gas through a distal end of the cannula.

In an embodiment, the portion of the housing base, by displacing thethreaded elements and the stopper, is configured to expel at least someof the substance through the distal end of the cannula.

In an embodiment, the portion of the housing base is disposed withrespect to a portion at a proximal end of the vial such that, during theinsertion of the vial and the threaded elements into the housing base,relative motion between the portion of the housing base and the portionat the proximal end of the vial displaces the threaded elements and thestopper toward the distal end of the vial.

In an embodiment, the portion of the housing base is disposed such thatsliding motion between the portion of the housing base and the portionat the proximal end of the vial advances the threaded elements and thestopper toward the distal end of the vial.

In an embodiment, the apparatus further includes: at least one cog thatis couplable to a proximal end of the first threaded element andconfigured to rotate the first threaded element by rotating; a motorconfigured to rotate the cog; and a housing top, to which the cog andthe motor are coupled.

In an embodiment, the apparatus further includes a control unit coupledto the motor, and the control unit is configured to receive a codedindication of a characteristic of the substance, and to control themotor in response to the indication of the characteristic of the substance.

In an embodiment, the apparatus further includes a control unit coupledto the motor, and the control unit is programmable and is configured tobe programmed to administer a basal rate of the substance to the subjectby controlling the motor.

In an embodiment, the apparatus further includes a control unit coupledto the motor, and the control unit is configured to receive an input andto administer a bolus of the substance to the subject responsively tothe input.

In an embodiment, the apparatus further includes: a control unit coupledto the motor; and a sensor configured to detect a physiologicalparameter of the subject and to transmit a signal to the control unitresponsively to the parameter, and the control unit is configured tocontrol the motor responsively to the signal.

In an embodiment, the sensor is configured to be implanted in thesubject's body.

In an embodiment, the sensor is configured to transmit the signalwirelessly.

In an embodiment, the apparatus further includes a housing baseconfigured to hold the vial, and the housing base and the housing topare configured to be coupled together by the subject prior to theadministering of the substance, and decoupled from each other by thesubject following the administering of the substance.

In an embodiment, the housing top is configured to be reused subsequentto the administering of the substance from the vial, and the housingbase and the threaded elements are configured to be discarded subsequentto the administering of the substance from the vial.

In an embodiment, the apparatus further includes: one or more magneticelements coupled to the housing base; and one or more magnetic elementscoupled to the housing top, and the magnetic elements are configured toreversibly magnetically couple the housing base to the housing top whenthe housing base and housing top are aligned.

In an embodiment, the apparatus further includes: a housing base, andthe vial and the threaded elements are configured to be inserted intothe housing base; a needle coupled to the housing base; and a cannula atleast partially disposed around the needle, the needle is configured topierce skin of the subject and insert the cannula into the subject'sskin, the needle is configured to retract subsequent to piercing, andthe apparatus is configured to administer the substance to the subjectvia the cannula.

In an embodiment, the apparatus further includes a needle activationmechanism coupled to the needle, the needle activation mechanismincluding: a subject-contact surface for application thereto of a forceby the subject; and a force-receiving element which is configured to bedisplaced when the force applied by the subject to the subject-contactsurface exceeds a threshold force, and the needle is configured torapidly pierce the skin in response to displacement of theforce-receiving element due to the force exceeding the threshold force.

In an embodiment, the apparatus further includes a spring, and thespring is configured to retract the needle subsequent to the piercing.

In an embodiment, the apparatus further includes: a housing base, thevial and the threaded elements being configured to be inserted into thehousing base; and a needle coupled to the housing base and configured topierce skin of the subject, and the apparatus is configured toadminister the substance to the subject via the needle.

In an embodiment, the apparatus is configured to administersubstantially all of the substance in less than one hour.

In an embodiment, the substance includes glatiramer acetate and theapparatus is configured to deliver the glatiramer acetate to the subjectvia the needle.

In an embodiment, the apparatus further includes: a housing base, thevial and the threaded elements being configured to be inserted into thehousing base; and a plurality of microneedles coupled to the housingbase and configured to pierce skin of the subject, and the apparatus isconfigured to administer the substance to the subject via the pluralityof microneedles.

In an embodiment, a diameter of each of the microneedles is less than150 microns.

In an embodiment, the first threaded element includes a screw, and thesecond threaded element includes a nut disposed at least partiallyaround the screw.

In an embodiment, the screw includes a telescopic screw, and the screwis configured to advance a distal end of the nut toward the distal endof the vial by extending the telescopic screw toward the distal end ofthe vial.

In an embodiment, the telescopic screw includes two at least partiallyoverlapping portions.

In an embodiment, the telescopic screw includes three or more at leastpartially overlapping portions.

In an embodiment, the nut includes a telescopic nut, and the screw isconfigured to advance a distal end of the nut toward the distal end ofthe vial by extending the telescopic nut toward the distal end of thevial.

In an embodiment, the telescopic nut includes two at least partiallyoverlapping portions.

In an embodiment, the telescopic nut includes three or more at leastpartially overlapping portions.

In an embodiment, the first threaded element includes a nut, and thesecond threaded element includes a screw disposed at least partiallyinside the nut.

In an embodiment, the screw includes a telescopic screw, and the nut isconfigured to advance a distal end of the screw toward the distal end ofthe vial by extending the telescopic screw toward the distal end of thevial.

In an embodiment, the telescopic screw includes two at least partiallyoverlapping portions.

In an embodiment, the telescopic screw includes three or more at leastpartially overlapping portions.

In an embodiment, the nut includes a telescopic nut, and the nut isconfigured to advance a distal end of the screw toward the distal end ofthe vial by extending the telescopic nut toward the distal end of thevial.

In an embodiment, the telescopic nut includes two at least partiallyoverlapping portions.

In an embodiment, the telescopic nut includes three or more at leastpartially overlapping portions.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method, including: providing: a vial that containsa substance, and is sealed by a stopper, and first and second threadedelements for placement within the vial, the first and second threadedelements being threadedly coupled to each other, a distal end of thesecond threaded element being for coupling to the stopper; inserting thevial into a housing base, the threaded elements having been insertedinto the vial, and the distal end of the second threaded element havingbeen coupled to the stopper; and pushing the substance out of the vialby advancing the stopper and at least the distal end of the secondthreaded element toward a distal end of the vial, the advancing beingperformed by: rotating the first threaded element with respect to thevial, impeding proximal linear motion of the first threaded element withrespect to the vial during rotation of the first threaded element, andimpeding rotational motion of at least the distal end of the secondthreaded element with respect to the vial.

There is further provided, in accordance with an embodiment of thepresent invention, apparatus for administering a substance to a subject,including: a vial that contains the substance; a stopper within thevial, slidably coupled to the vial; a shaft within the vial, a distalportion of the shaft being coupled to the stopper; and a rotationmechanism disposed proximally to the vial, coupled to the shaft andconfigured to linearly advance the stopper toward a distal end of thevial by rotating the shaft, and at all times during the rotating of theshaft, (a) a distal end of the shaft is configured to remain proximal toa distal end of the stopper, and (b) a proximal end of the shaft isconfigured to remain distal to a proximal end of the rotation mechanism.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method, including: providing a vial that contains asubstance, is sealed by a stopper, and has therein a shaft that iscoupled to the stopper; inserting the vial into a housing base, arotation mechanism being coupled to the housing base proximally to thevial; pushing the substance out of the vial by advancing the stopper byrotating the shaft; maintaining a distal end of the shaft proximal to adistal end of the stopper at all times during the rotating of the shaft;and maintaining a proximal end of the shaft distal to a proximal end ofthe rotation mechanism at all times during the rotating of the shaft.

There is further provided, in accordance with an embodiment of thepresent invention, apparatus for administering a substance to a subject,including: a vial that contains the substance; a stopper within thevial, slidably coupled to the vial; a first threaded element (a)rotatable with respect to the vial and (b) substantially immobileproximally with respect to the vial during rotation of the firstthreaded element; and a second threaded element that is threadedlycoupled to the first threaded element, at least a distal end of thesecond threaded element substantially non-rotatable with respect to thevial, the distal end of the second threaded element remaining proximalto a distal end of the stopper at all times during rotation of the firstthreaded element, and the first threaded element, by rotating, linearlyadvancing the stopper and at least the distal end of the second threadedelement toward a distal end of the vial.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method, including: providing: a vial that containsa substance, and is sealed by a stopper, and [0158] first and secondthreaded elements for placement within the vial, the first and secondthreaded elements being threadedly coupled to each other, a distal endof the second threaded element being for coupling to the stopper;inserting the vial into a housing base, the threaded elements havingbeen inserted into the vial, and the distal end of the second threadedelement having been coupled to the stopper; pushing the substance out ofthe vial by advancing the stopper and at least the distal end of thesecond threaded element toward a distal end of the vial, the advancingbeing performed by: rotating the first threaded element with respect tothe vial, impeding proximal linear motion of the first threaded elementwith respect to the vial during rotation of the first threaded element,and impeding rotational motion of at least the distal end of the secondthreaded element with respect to the vial; and maintaining the distalend of the second threaded element proximal to a distal end of thestopper at all times during the rotating of the first threaded element.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofa preferred embodiment of the invention, will be better understood whenread in conjunction with the appended drawings. For the purpose ofillustrating the invention, there are shown in the drawings anembodiment which is presently preferred. It should be understood,however, that the invention is not limited to the precise arrangementsand instrumentalities shown.

In the drawings:

FIG. 1A is a schematic illustration of apparatus for administering asubstance to a subject, in accordance with an embodiment of the presentinvention;

FIG. 1B is a schematic illustration of the apparatus of FIG. 1A on asubject's body, a sensor for use with the apparatus being disposedinside the subject's body, in accordance with an embodiment of thepresent invention;

FIG. 2 is a schematic exploded view of the apparatus of FIG. 1, inaccordance with an embodiment of the present invention;

FIG. 3 is a schematic illustration of a housing base of the apparatus ofFIG. 1, in accordance with an embodiment of the present invention;

FIG. 4 is a schematic illustration of a vial being inserted into thehousing base of FIG. 3, in accordance with an embodiment of the presentinvention;

FIG. 5A is a schematic illustration of a vial inserted in the housingbase, in accordance with an embodiment of the present invention;

FIG. 5B is a schematic illustration of a housing top coupled to thehousing base, in accordance with an embodiment of the present invention;

FIGS. 6A-D are schematic cross-sectional illustrations, taken along lineVI of FIG. 5A, of the vial at respective stages of use of the apparatus,in accordance with an embodiment of the present invention;

FIG. 6E is a force vector diagram showing the forces acting on a stopperduring operation of the apparatus, in accordance with an embodiment ofthe present invention;

FIGS. 7A-C are schematic cross-sectional illustrations, taken along lineVII of FIG. 5A, of an activation mechanism of the apparatus atrespective stages of operation of the apparatus, in accordance with anembodiment of the present invention;

FIGS. 8A-B are schematic illustrations of a vial, in accordance with anembodiment of the present invention;

FIGS. 9A-B are schematic illustrations of a double-chambered vial, inaccordance with an embodiment of the present invention;

FIGS. 10A-B are schematic illustrations of a double-chambered vial, inaccordance with an alternative embodiment of the present invention;

FIG. 11 is a schematic illustration of a vial, in accordance with anembodiment of the present invention;

FIGS. 12A-B are schematic illustrations of a vial containing atelescopic screw, in accordance with respective embodiments of thepresent invention;

FIG. 13 is a schematic illustration of a vial containing a telescopicnut, in accordance with an embodiment of the present invention; and

FIG. 14 is a schematic illustration of apparatus including a vialhousing unit and a separate needle housing unit, in accordance with anembodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right,” “left,” “lower” and “upper”designate directions in the drawings to which reference is made. Thewords “inwardly” and “outwardly” refer to directions toward and awayfrom, respectively, the geometric center of the device and designatedparts thereof. Unless specifically set forth herein, the terms “a”, “an”and “the” are not limited to one element but instead should be read asmeaning “at least one”. The terminology includes the words noted above,derivatives thereof and words of similar import.

Reference is now made to FIGS. 1A-B and 2, which are schematicillustrations of apparatus 20 for administering a substance, forexample, insulin, to a subject, in accordance with an embodiment of thepresent invention. Typically, apparatus 20 comprises a vial 22 thatcontains the substance to be administered to a subject. Vial 22 issealed at its proximal end by a stopper 24. A first threaded element 26(e.g., a screw, as shown) is disposed at least in part within the vial,and a second threaded element 28 (e.g., a nut, as shown) is alsodisposed within the vial, threadedly coupled to the first threadedelement. The distal end of the second threaded element defines acoupling portion 30 that couples the second threaded element to thestopper. The first threaded element is rotated by a rotation mechanism(e.g., motor 50), and by rotating, linearly advances the second threadedelement and the stopper toward a distal end of the vial, withoutsubstantially rotating the second threaded element or the stopper.

In some embodiments, first threaded element 26 is a nut and secondthreaded element 28 is a screw disposed at least in part inside the nut.The nut is configured to rotate and to cause the screw and the stopperto advance toward a distal end of the vial due to the rotation of thenut. Alternatively, the first threaded element is a first screw and thesecond threaded element is a second screw. The first screw isconfigured, by rotating, to advance the second screw and the stoppertoward the distal end of the vial. In general, apparatus 20 comprises afirst threaded element that rotates, but is substantially immobilelinearly during rotation of the first threaded element, and a secondthreaded element that (a) is substantially non-rotatable, (b) moveslinearly toward the distal end of the vial in response to the rotationof the first threaded element, and (c) is coupled to the stopper. Thefirst threaded element is rotated, causing the second threaded elementand the stopper to advance distally.

Typically, vial 22 is inserted into a housing base 32. In someembodiments, portion 34 of the housing base is configured to impedeproximal linear motion of first threaded element 26. (In the context ofthe present patent application and in the claims, the term “proximal”denotes a position toward an end 38 of the vial. The term “distal”denotes a position toward an end 36 of the vial, out of which thesubstance is administered to the subject.) In some embodiments, duringrotation of first threaded element 26, stopper 24 is configured toimpede rotation of second threaded element 28. Typically, friction ofthe stopper against the inside of the vial impedes rotational motion ofthe stopper, and element 28 being coupled to the stopper is similarlyimpeded. Thus, as first threaded element 26 is rotated, second threadedelement 28 and the stopper advance linearly toward distal end 36 of thevial. In some embodiments, a standard, commercially-available vial andstopper are used as vial 22 and stopper 24. For some applications, thefirst and second threaded elements are standard, commercially-availablethreaded elements, e.g., a standard commercially-available screw andnut. Friction between the stopper and the vial impedes rotation of thestopper, while allowing distal movement of the stopper within the vial,as described in further detail herein below, with reference to FIGS. 6Cand 6E.

For some applications, rotation of the second threaded element isimpeded by other means, for example, as described herein below.

For some applications, the initial position of stopper 24 in vial 22 isin accordance with the amount of the substance that is contained withinthe vial and that is to be administered to the subject. The lengths offirst and second threaded elements 26 and 28 are typically such thatwhen the threaded portions of the elements are maximally overlapping(i.e., fully screwed together), and the elements are disposed within thevial, coupling portion 30 couples the second threaded element to thestopper. For example, the lengths of the screw and the nut, shown inFIG. 2, are typically such that when the screw is maximally insertedwithin the nut, and the screw and nut are disposed within the vial,coupling portion 30 of the nut couples the nut to the stopper. Forexample, if the vial contains a small amount of the substance prior toadministering the substance, then stopper is disposed toward distal end36 of the vial. In such a case, a relatively long screw/nut assembly (orscrew/screw assembly) is designated to be disposed within the vial, sothat coupling portion 30 couples the nut to the stopper. If, on theother hand, a large volume of the substance is contained within thevial, then a relatively short screw/nut assembly (or screw/screwassembly) is typically disposed within the vial. For some applications,screw/nut assemblies (or screw/screw assemblies) are color-coded orotherwise marked to indicate which screw/nut assembly (or screw/screwassembly) is suitable for use with which initial volume of substance.

In an alternative embodiment, first and second threaded elements 26 and28 are placed in the vial, without being selected based on the initialvolume of substance, and the elements are unscrewed from each other asuitable amount in order to facilitate the coupling of coupling portion30 to the stopper.

Typically, a distal end 40 of the first threaded element 26 isconfigured to remain proximal to the stopper, or proximal to distal end43 of the stopper, at all times during the rotating of the firstthreaded element. Further typically, the distal end of the secondthreaded element remains proximal to the distal end of the stopper atall times during the rotation of the first threaded element. The stoppertypically provides a seal between a first portion of the vial, which isdistal to the stopper, and a second portion of the vial, which isproximal to the stopper. In some embodiments, the sterility of thesubstance disposed in the first portion is maintained by the stopperproviding a seal between the first portion and the second portion,threaded elements being disposed in the second portion. The first andsecond threaded elements assembly may be viewed as a shaft that convertsthe rotational motion of motor 50 to distal advancement of stopper 24.Typically, at all times during the rotating of the shaft, (a) the distalend of the shaft (i.e., the distal end of the second threaded element)is configured to remain proximal to a distal end of the stopper, and (b)the proximal end of the shaft (i.e., the proximal end of the firstthreaded element) is configured to remain distal to a proximal end ofthe rotation mechanism.

For some applications, a vial piercing mechanism 44 is movably (e.g.,rotatably) coupled to housing base 32. As part of the insertion of vial22 into the housing base, a seal 46 at distal end 36 of the vial ispierced by pressing the seal against the piercing mechanism. Thesubstance is configured to subsequently flow through a tube 53 toward anactivation mechanism 56, which is typically coupled to the housing base,and is configured to insert a cannula and/or a needle through thesubject's skin and to deliver the substance via the cannula and/or theneedle.

Although first and second threaded elements 26 and 28 have beendescribed as being within vial 22 (e.g., the apparatus may be bought bythe subject with the threaded elements already within the vial), in someembodiments, the threaded elements are inserted into the vial and arecoupled to stopper 24 by the subject and/or by a healthcare provider. Insome embodiments, vial 22 and stopper 24 are a standard,commercially-available vial and stopper, for example, the vial may be acircular barrel with a smooth inner wall. The first and second threadedelements are inserted into the vial and coupled to the stopper, and theapparatus dispenses the substance, in accordance with the techniquesdescribed hereinabove. The friction between the standard stopper and thestandard vial prevent the second threaded element from rotating due tothe coupling of the second threaded element to the stopper, as describedhereinabove. For some applications, providing the apparatus describedherein for use with standard, commercially-available vials and stoppersprovides a commercial advantage.

For some applications, the threaded elements are coupled to housing base32, and the subject and/or a healthcare provider moves the vial withrespect to the housing base in order to couple the stopper to the secondthreaded element. For example, a standard, commercially-available vialand stopper may be moved with respect to the housing base, in order tocouple the stopper to the second threaded element, the threaded elementsbeing coupled to the housing base.

In some embodiments, a housing top 48 is coupled by the subject tohousing base 32. The housing top typically comprises a motor 50 and abattery 58. (In an embodiment, the battery is coupled to housing base32.) For some applications, a first cog 52 (i.e., a motor cog) iscoupled to housing base 32. The motor is configured to rotate the firstcog 52, and the first cog 52 is configured to rotate first threadedelement 26. Typically, first cog 52 engages a second cog 54, the secondcog 54 being coupled to the proximal end of threaded element 26, and/orcomprising the proximal portion of threaded element 26. In someembodiments, only a single cog is used, the single cog being coupled toand/or comprising a proximal portion of threaded element 26, and thesingle cog being rotated directly by the motor. Alternatively oradditionally, other techniques known in the art are used for convertingmotion from a motor to rotational or linear motion.

For some applications, the subject reversibly couples the housing top tohousing base 32. Following the termination of the delivery of thesubstance to the subject from vial 22, the subject and/or a healthcareprovider decouples the housing top from the housing base. In someembodiments, the housing top is configured to be re-used with anotherhousing base, and the housing base is configured to be discarded after asingle use. For some applications, the housing top and the housing basecomprise magnetic materials 59 that are configured to releasably couplethe housing top to the housing base when the top and the base arealigned.

For some applications, a control unit 51 is coupled to motor 50. In someembodiments, the control unit administers a basal rate of the substanceto the subject by controlling the motor. Alternatively or additionally,the control unit is configured to receive an input and to administer abolus of the substance to the subject responsively to the input. Forexample, housing top 48 may comprise two buttons. When both buttons arepressed at the same time, the control unit is configured to administer abolus of the drug. Alternatively, a button 80 associated with activationmechanism 56 may be configured to cause the control unit to administer abolus of the drug, when pushed subsequent to the insertion mechanismhaving been activated. Further alternatively or additionally, a sensor57 (shown in FIG. 1B) is configured to detect one or more physiologicalparameters of the subject. The control unit is configured to control theadministering of the substance in response to the detected parameters.In some embodiments, the sensor is configured to be implanted in thesubject. For some applications, the sensor transmits the detectedparameters to the control unit wirelessly.

In some embodiments, vial 22 has a distal compartment which contains apowder, and a proximal compartment which contains a liquid. The distalcompartment and the proximal compartment are reversibly separated by adividing stopper 134 (shown in FIGS. 9A-B). First threaded element 26,by rotating, causes the powder and the liquid to mix by advancing thedividing stopper toward distal end 36 of the vial, as described indetail herein below, with reference to FIGS. 9A-B.

Reference is now made to FIGS. 3 and 4, which are respectively aschematic illustration of housing base 32, and a schematic illustrationof vial 22 being inserted into the housing base, in accordance with anembodiment of the present invention. The housing base, as shown in FIG.3, is prepared for the insertion of vial 22. The distal end of the vialis inserted into vial piercing mechanism 44, which pierces the seal atthe distal end of the vial. The vial is then lowered into the housingbase. Typically, opposing resilient arms 70 support the vial upon thehousing base.

In some embodiments, as vial 22 is lowered into housing base 32, firstcog 52 engages second cog 54. For some applications, as the vial islowered, portion 34 of the housing base automatically displaces firstand second threaded elements 26 and 28 (and therefore stopper 24) towarddistal end 36 of the vial. In some embodiments, the stopper is disposedwithin the vial such that before the insertion of the vial into thehousing, first threaded element 26 protrudes a distance h from theproximal end of the vial. The proximal end of the first threaded element(or of second cog 54) comprises a rounded portion 74. Portion 34 of thehousing base comprises an angled face 76. As rounded portion 74 slidespast the angled face, the first threaded element is pushed the distanceh inside the vial. As a result, the threaded elements and the stopperare displaced toward the distal end of the vial.

In some embodiments, apparatus 20 comprises alternative means of pushingthreaded elements 26 and 28 inside vial 22 during the insertion of thevial into housing base 32. For example, the proximal end of firstthreaded element 26 may comprise an angled face and portion 34 of thehousing base may comprise a rounded portion. Alternatively, both theproximal end of the first threaded element and portion 34 of the housingmay comprise an angled face and/or a rounded portion.

For some applications, portion 34 of housing base 32 is configured toapply a sufficient force, in displacing threaded elements 26 and 28 andstopper 24, to overcome friction between stopper 24 and vial 22 that isdue to prolonged storage of the stopper in contact with the vial. Forexample, the stopper may have been stored in contact with the innersurface of the vial for a period of at least one week or longer, as aresult of which the stopper may have a higher effective static frictionthan would have existed if the stopper had been recently moved withrespect to the vial. Alternatively or additionally, apparatus 20comprises a cannula 100 and/or a needle 102 (as shown in FIGS. 7A-C),configured to be inserted in the subject's skin. Portion 34 of thehousing base, by displacing the threaded elements and the stopper, isconfigured to expel gas through a distal end of the cannula and/orneedle. In some embodiments, in addition to expelling the gas, portion34 is configured to expel at least some of the substance therefrom, as aresult of displacing the threaded elements and the stopper. Typically,the expelling of the substance from the distal end of the cannula beforethe cannula is inserted into the subject's skin increases the accuracyof the first dosage administered, because the initial activation of themotor essentially immediately administers the substance, withoutpreviously ejecting gas stored in the vial or conduits of apparatus 20.

Reference is now made to FIGS. 5A and 5B, which are respectively aschematic illustration of vial 22 inserted in housing base 32, and ofhousing top 48 coupled to housing base 32, in accordance with anembodiment of the present invention. Housing top 48 is shaped such thatwhen it is coupled to the housing base, button 80 of activationmechanism 56 is accessible to be pressed by the subject.

Reference is now made to FIGS. 6A-E. FIGS. 6A-D are schematiccross-sectional illustrations of vial 22 at respective stages of use ofapparatus 20, in accordance with an embodiment of the present invention.FIG. 6E is a force vector diagram showing the forces acting on stopper24 during rotation of first threaded element 26, in accordance with anembodiment of the present invention.

FIG. 6A shows vial 22 before its insertion into housing base 32. Firstthreaded element 26 (e.g., a screw, as shown) protrudes by distance hfrom proximal end 38 of the vial. Second threaded element 28 (e.g., anut, as shown) is threadedly coupled to the first threaded element andis coupled to stopper 24 via coupling portion 30. For example, couplingportion 30 may be shaped to define teeth 90, which are inserted into thestopper. Or, coupling portion 30 may be a flat surface that is flushwith a proximal end 42 of stopper 24, or that is otherwise in contactwith the stopper.

During insertion of the vial into the housing base, the first and secondthreaded elements and the stopper are displaced toward distal end 36 ofthe vial, as shown in FIG. 6B.

First threaded element 26 rotates during administration of the substanceto the subject. Rotational motion of second threaded element 28 isimpeded (even if not necessarily eliminated) by stopper 24 to which thesecond threaded element is coupled, and/or rotational motion of thesecond threaded element is impeded by alternative means, for example, asdescribed with reference to FIGS. 8A-B. Additionally, proximal linearmotion of the first threaded element with respect to the vial is impeded(by portion 34 of housing base 32, not shown) during rotation of thefirst threaded element. The rotation of the first threaded elementcombined with the impeded rotation of the second threaded elementresults in the second threaded element and the stopper advancing towarddistal end 36 of vial 22, as shown in FIGS. 6C and 6D.

Typically, due to the rotation of the first threaded element, a linearforce FL and a rotational force FR act on stopper 24, as shown in FIG.6E. A linear friction force FFL between the stopper and vial 22 acts tooppose the linear advancement of the stopper, and a rotational frictionforce FFR between the stopper and the vial acts to oppose rotation ofthe stopper. Further typically, and as described in detail in thefollowing paragraphs, friction between the stopper and the vial acts tooppose rotation of the stopper to a greater extent than it acts tooppose linear advancement of the stopper through the vial. Inparticular, in this embodiment, rotation of the stopper by (for example)a full rotation is impeded to a much greater extent than forward motionof the stopper by the pitch of the threaded elements is impeded, becausesignificantly more friction must be overcome to produce a full rotationof the stopper than would need to be overcome in order for the stopperto advance the distance of the pitch of the threaded elements. As aresult, friction generally acts to impede rotation of the stopper, whileallowing distal movement of the stopper within the vial.

In a more detailed analysis of this effect, it is noted that, in someembodiments, friction between the stopper and the vial has theaforementioned effect due to selection of a suitable ratio of (a) themaximal diameter D of the first threaded element (shown in FIG. 6C) to(b) the pitch P of the first threaded element. Typically, the ratio ofthe maximal diameter D to the pitch P is 3:1 to 30:1, for example, 6:1to 20:1, or 8:1 to 15:1. In some embodiments, the ratio is 6:1 to 15:1,for example, 10:1. The pitch of the second threaded element is equal tothe pitch of the first threaded element. Proximal linear motion of thefirst threaded element is impeded (as described hereinabove). Therefore,when the first threaded element rotates and the second threaded elementunscrews from the first threaded element, the second threaded elementmust either rotate, advance distally, or both rotate and advancedistally.

By way of example, the first threaded element may have a maximaldiameter of 8 mm and a pitch of 1 mm (i.e., a ratio of maximal diameterto pitch of 8:1). Accordingly, the outer perimeter of the first threadedelement is greater than 25 mm (pi multiplied by the maximal diameter).As the first threaded element rotates through 360 degrees, if the secondthreaded element were to unscrew from the first threaded element byrotating, the second threaded element would rotate through a distance ofmore than 25 mm, around the perimeter of the first threaded element.Accordingly, the outer surface of the stopper would rotate in contactwith the inner surface of the vial through an even greater distance,such as 40 mm (since the outer diameter of the stopper is greater thanthat of the first threaded element, as seen, for example, in any ofFIGS. 6A-D). Alternatively, if the second threaded element unscrews fromthe first threaded element by advancing linearly through the vial, itadvances by a distance of 1 mm, i.e., by a distance that is equal to thepitch of the threaded elements. Accordingly, in the presence ofsignificant, intentionally-generated friction, the stopper advancessubstantially only linearly (in contact with the inner surface of thevial) by a distance of 1 mm, while rotating only to a relatively smallextent.

It is noted that in some embodiments, friction between the stopper andthe vial acts to impede rotation of the stopper, while allowing distalmovement of the stopper within the vial, generally irrespective of theratio of the maximal diameter D to the pitch P of the first threadedelement.

As disclosed hereinabove, in some embodiments, friction acts to impederotation of the stopper, while allowing distal movement of the stopperwithin the vial, even when the apparatus disclosed herein is used inconjunction with standard, commercially-available vials, stoppers, andthreaded elements.

Reference is now made to FIGS. 7A-C, which are schematic illustrationsof activation mechanism 56 of apparatus 20 at respective stages ofoperation of the apparatus, in accordance with an embodiment of thepresent invention. Typically, following the insertion of vial 22 intohousing base 32, and the coupling of housing top 48 to the housing base,the bottom surface of the housing base is adhered to the subject's skin(e.g., with an adhesive), as shown in FIG. 1B. Subsequently, theactivation mechanism is activated.

FIG. 7A shows activation mechanism 56 before the activation mechanismhas been activated. Needle 102 is disposed within the activationmechanism, and cannula 100 is disposed around the outside of the needle.When the bottom surface of housing base 32 is adhered to the subject'sskin, the subject pushes button 80, which is accessible through housingtop, as shown in FIG. 5B. Until the force of the pushing of the buttonexceeds a threshold force, friction between a protrusion 104 of astructural element 103 and force receiving element 106 prevents thebutton and the needle being pushed down. (Force receiving element 106 istypically a surface of a holding portion 108, described herein below.)When the button is pushed by the subject with a force that exceeds thethreshold force, force receiving element 106 is suddenly and rapidlypushed aside by protrusion 104. Typically, by applying sufficient forceto the button to overcome the resistive force of force receiving element106, the subject applies a level of force which is sufficient tosuddenly and rapidly insert the needle and cannula into the subject'sskin. FIG. 7B shows the needle and cannula having been advanced due tobutton 80 having been pushed with a force that exceeds the thresholdforce.

The pushing of button 80 with sufficient force causes structural element103 to advance toward the subject's skin. When the structural elementarrives at the end of its travel, it is held in place by holding portion108. For example, a proximal portion of protrusion 104 may be secured bya distally-directed force applied thereto by a distal portion of forcereceiving element 106, constituting holding portion 108, as shown inFIG. 7B. When the subject releases button 80, as shown in FIG. 7C, aspring 110 pushes the button up, which retracts needle 102 back insidehousing base 32. Cannula 100 is coupled to structural element 103, whichis held in place by holding portion 108. Therefore, the cannula remainsinserted in the patient's skin. The substance is administered to thesubject via the cannula.

In an alternative embodiment, the substance is administered to thesubject via needle 102, the needle remaining inserted in the subject'sskin for the duration of the administration. In such an embodiment,apparatus 20 is typically configured to administer substantially all ofthe substance to the subject in less than one hour. For example,Copaxone® (or another drug) may be administered to the subject in thismanner over the course of approximately one half hour.

In some embodiments, needle 102 comprises a plurality of microneedles,which are inserted into the subject's skin, and the substance isadministered to the subject via the microneedles. Typically, thediameter of each of the microneedles is about 50-150 microns, e.g.,about 100 microns, and the length of each of the microneedles is about200-1000 microns.

In an embodiment, control unit 51 is configured to receive anindication, on vial 22, first threaded element 26, second threadedelement 28, or another element, that indicates a characteristic of thecontents of vial 22. For example, a barcode, RFID, mechanical code, orother code may indicate to the control unit the type of pharmaceuticalproduct in the vial, the quantity of the substance, or a dosage schedulefor administration of the substance. Typically, when the subject firstreceives the vial, stopper 24 is already in place within the vial at thecorrect position for initiating delivery of the substance.

Reference is now made to FIGS. 8A-B, which are schematic illustrationsof respective views of vial 22, in accordance with an embodiment of thepresent invention. For some applications, a protrusion 120 protrudesfrom inner surface 122 of the vial, and second threaded element 28 is anut that is shaped to define a groove 124 on its outer surface. As thenut advances toward the distal end of the vial, groove 124 slides alongprotrusion 120, preventing the nut from rotating. Alternatively oradditionally, stopper 24 is shaped to define a groove on its outersurface, the groove preventing the stopper, and therefore the secondthreaded element, from rotating. In some embodiments, inner surface 122of vial 22 is not round, but, for example, is square, oval, orrectangular. The outer surface of the second threaded element, and/orthe stopper, is shaped similarly to the inner surface of the vial. Theshapes of inner surface 122, and the outer surface of the secondthreaded element and/or the stopper, prevent the second threaded elementfrom rotating.

In some embodiments, vial 22 contains (for example, the vial may becomposed of) a cyclic olefin polymer, such as Crystal Zenith®. In someembodiments, manufacturing the vial using a cyclic olefin polymerfacilitates the molding of protrusion 120. For some applications,stopper 24 is coated with a fluoropolymer. Typically, using a vial thatcontains a cyclic olefin polymer, and/or a stopper that is coated with afluoropolymer maintains the stability of a substance that is disposedwithin the vial. For example, the vial may be used to administer amonoclonal antibody to the subject, and the composition of the vial, thestopper, and/or the second threaded element may maintain the stabilityof the monoclonal antibody.

In some embodiments, the proximal end of vial 22 is shaped to define twoor more flanges 123. Typically, the flanges facilitate the filling ofthe vial. For example, during the filling of the vial, the vial may beplaced inside a hole of a tray, and the flanges may support the vialinside the hole. In some embodiments, the flanges are configured to holdthe vial in a fixed position inside housing base 32.

Reference is now made to FIGS. 9A-B, which are schematic illustrationsof vial 22, in accordance with an embodiment of the present invention.In some embodiments, the vial contains a distal compartment 130, and aproximal compartment 132, a dividing stopper 134 inhibiting fluidcommunication between the proximal and distal compartments. In someembodiments, a powder (for example, medication that is in the form of apowder) is disposed in distal compartment 130 and a liquid (e.g. water,saline, and/or a medication) is disposed in proximal compartment 132. Assecond threaded element 28 is advanced distally through the vial,dividing stopper 134 is advanced distally. The advancement of thedividing stopper exposes compartment 132 to conduit 136. As secondthreaded element 28 is further advanced, stopper 24 causes the liquid toflow into distal compartment 130 via the conduit, in the direction ofarrow 138 (as shown in FIG. 9B). The liquid and the powder then mix and,for example, may form a solution or a suspension, before beingadministered to the subject. In some embodiments, a first liquidmedication is disposed in distal compartment 130 and a second liquidmedication is disposed in proximal compartment 132. Dividing stopper 134inhibits fluid communication between the first and second medications.As second threaded element 28 advances through the vial, the twomedications mix before being administered to the subject.

Reference is now made to FIGS. 10A-B, which are schematic illustrationsof vial 22, in accordance with an embodiment of the present invention.The vial contains a distal compartment 130, and a proximal compartment132, dividing stopper 134 inhibiting fluid communication between theproximal and distal compartments. In some embodiments, a medication isdisposed in the distal compartment, and a flushing solution, such aswater or saline, is disposed in the proximal compartment. As secondthreaded element 28 is advanced distally through the vial, dividingstopper 134 is advanced distally, thereby administering to the subjectthe medication disposed in proximal compartment 130. When dividingstopper 134 is advanced to a position toward distal end 36 of the vialthe flushing solution flows through conduit 140 (in the direction ofarrow 142) and flushes the medication from the vial and/or from conduitsof apparatus 20.

It is noted that the term “providing” as used herein in thespecification and in the claims, in the context of providing apparatus(for example, providing a vial), includes within its scope the apparatusbeing provided by the user of the apparatus, and is not limited to thesale of the apparatus.

Reference is now made to FIG. 11, which is a schematic illustration ofvial 22, in accordance with an embodiment of the present invention. Insome embodiments, first threaded element 26 is a nut that is rotatablewith respect to vial 22. Second threaded element 28 is a screw that isthreadedly coupled to the nut and disposed at least partially within thenut. During rotation of the nut, linear motion of the nut with respectto the vial is impeded (for example, by portion 34 of housing base 32,shown in FIG. 4). During rotation of the nut, the screw is substantiallyrotationally immobile with respect to the vial. Typically, the distalend of the screw is coupled to stopper 24 via coupling surface 30, andthe stopper impedes rotation of the screw. Thus, during rotation of thenut, the screw and the stopper advance toward distal end 36 of the vialand administer the substance to the subject from the vial.

In some embodiments (as shown in FIG. 11), the distal end of the secondthreaded element is disposed inside stopper 24. Although FIG. 11 showsthe distal end of a screw disposed inside the stopper, the scope of thepresent application includes having the distal end of any embodiment ofthe second threaded element disposed inside stopper 24, in accordancewith any of the methods or apparatus described herein. For example, thesecond threaded element may be a nut, e.g., as shown in FIGS. 6A-D, thedistal end of the nut being disposed inside the stopper instead of beingcoupled to the proximal end of the stopper, as shown in FIGS. 6A-D.Typically, using a second threaded element that is disposed inside thestopper facilitates the use of a vial having a shorter length than wouldbe necessary if the second threaded element was not disposed inside thestopper.

Reference is now made to FIGS. 12A-B, which are schematic illustrationsof vial 22 containing a telescopic screw 150, in accordance with anembodiment of the present invention. Vial 22 of FIG. 12 is generallysimilar to vial 22 described with reference to FIG. 11, except fordifferences described herein below.

In some embodiments, the second threaded element is a telescopic screw.First threaded element, by rotating, extends the telescopic screw andadvances stopper 24 and distal end 152 of the telescopic screw towarddistal end 36 of vial 22, in accordance with the techniques describedhereinabove. In some embodiments, using a telescopic screw as the secondthreaded element facilitates the use of a smaller length vial toadminister a given amount of the substance than would be necessary if anon-telescopic screw, or a nut were used as the second threaded element.In some embodiments, a telescopic screw is used as the first threadedelement, and a nut is used as the second threaded element.

Although a telescopic screw having two overlapping portions 154 and 156is shown, the scope of the present invention includes using a screwhaving more three or more overlapping portions as the second threadedelement of vial 22. Typically, the ratio of the length of the telescopicscrew when fully extended to the length of the telescopic screw whenfully contracted (as shown in FIG. 12) is 1.5:1 to 2:1.

In some embodiments, as shown in FIG. 12B, a second threaded element(e.g., a nut or a screw) is used that is (a) telescopic, and (b)disposed at least partially inside stopper 24. For example, FIG. 12Bshows a telescopic screw, a distal end of which is disposed insidestopper 24. Typically, using a second threaded element that is (a)telescopic, and (b) disposed at least partially inside stopper 24facilitates the use of a shorter vial to administer a given amount ofthe substance than would otherwise be necessary, ceteris paribus.

Reference is now made to FIG. 13, which is a schematic illustration ofvial 22 containing a telescopic nut 160, in accordance with anembodiment of the present invention. For some applications, a telescopicnut, such as that described in U.S. Pat. No. 6,905,298 to Haring, isused as the first threaded element (configuration not shown) or as thesecond threaded element (as shown) inside vial 22. In an embodiment, thenut is configured such that frictional forces between a first portion164 and a second portion 166 of the nut prevent the first and secondportion from becoming disengaged from each other. In addition,frictional forces between the screw and portion 166 prevent the screwand portion 166 from becoming disengaged. For example, the threads atthe distal portion of the screw and on the inner surface of the proximalportion of portion 166 may widen, such that portion 166 cannot beunscrewed from the screw.

Vial 22 of FIG. 13 is generally similar to vial 22 described withreference to FIG. 12, except that a telescopic nut, instead of atelescopic screw, is used as the second threaded element. Although atelescopic nut having two overlapping portions 164 and 166 is shown, thescope of the present invention includes using a nut having three or moreoverlapping portions as the second threaded element of vial 22.Typically, the ratio of the length of the telescopic nut when fullyextended to the length of the telescopic nut when fully contracted (asshown in FIG. 13) is 1.5:1 to 2:1.

Reference is now made to FIG. 14, which is a schematic illustration ofapparatus 20 including a vial housing unit 170 and a separate needlehousing unit 172, in accordance with an embodiment of the presentinvention. The apparatus shown in FIG. 14 is generally similar to theapparatus shown in FIGS. 1 and 2, except for the differences describedherein below.

In some embodiments, activation mechanism 56 is housed in needle housingunit 172. The activation mechanism, as described hereinabove, insertscannula 100 and/or needle 102 through the subject's skin and deliversthe substance via the cannula and/or the needle. Vial 22 and controlcomponents, such as motor 50 and battery 58, are housed separately invial housing unit 170. In some embodiments, needle housing unit 172 isadhered to the subjects skin, and vial housing unit 170 is not adheredto the subject's skin. Typically, the needle housing unit and the vialhousing unit are not rigidly connected to each other. For example, vialhousing unit 170 may be worn on the subject's belt, or elsewhere on thesubject's clothing. Typically, vial housing unit 170 is coupled toneedle housing unit 172 via tube 53, via which the substance flows fromthe vial toward activation mechanism 56.

It is noted that, although a specific configuration of activationmechanism 56 is shown, in some embodiments, needle housing unit 172houses an activation mechanism having a different configuration. Forexample, needle housing unit 172 may house only cannula 100 and/orneedle 102. The subject inserts the needle into the subject's skin byadhering the needle housing unit to the skin.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

What is claimed is:
 1. An apparatus for administering a substance to asubject, the apparatus comprising: a housing including a housing baseand a housing top, the housing base having a bottom surface, the bottomsurface defining a base plane; an adhesive secured to the bottom surfaceof the housing base, the adhesive configured to secure the housing baseto skin of the subject in a mounted configuration; a substantiallycylindrical vial within the housing having a distal end, a proximal endand a longitudinal axis extending between the distal end and theproximal end, at least a portion of the substance located within thevial; a stopper slidably mounted within the vial, the stopper configuredfor movement along the longitudinal axis, the longitudinal axis beingsubstantially parallel to the base plane; a first threaded elementsecured to the stopper; an activation mechanism within the housing, theactivation mechanism including a movable button, a spring and a needlehaving a needle tip; the needle being in communication with the vial andoperatively connected to the button, the button movable between aninitial position, wherein the needle tip is positioned within thehousing and an extended position, wherein the needle tip extends out ofthe housing beyond the base plane, the button being biased toward theinitial position by the spring; a motor within the housing and a motorcog coupling the motor with the first threaded element, the motor beingconfigured to rotate the first threaded element via the motor cog, to,in turn, distally advance the stopper to push at least a portion of thesubstance out of the vial and through the needle; a battery within thehousing to power the motor; a control unit within the housing, thecontrol unit being in communication with the motor and the activationmechanism, the control unit configured to signal the motor to operatewhen the button moves from the initial position to the extendedposition; and a sensor configured to detect a parameter and transmit asignal to the control unit responsive to the parameter to control therotation of the motor.
 2. The apparatus of claim 1, wherein the sensoris configured to detect a physiological parameter of the subject and thesignal transmitted to the control unit relates to the detectedphysiological parameter.
 3. The apparatus of claim 1, wherein the sensoris configured to be implanted in the subject's body.
 4. The apparatus ofclaim 1, wherein the motor cog is a first cog rotatably secured to thehousing, the apparatus further comprising: a second cog secured to anend of the first threaded element; a second threaded element positionedat least partially within the vial; and the second threaded elementbeing in threaded engagement with the first threaded element, the secondcog being in threaded engagement with the first cog, the first cog inthreaded engagement with the motor the apparatus configured such thatactivation of the motor causes the first cog to rotate, the second cogto rotate, the first threaded element to rotate and the second threadedelement and the stopper to translate along the longitudinal axis toadminister at least a portion of the substance to the subject.
 5. Theapparatus of claim 1, wherein the sensor is comprised of a wirelesssensor.
 6. The apparatus of claim 1, further comprising: a vial piercingmechanism within the housing, the vial having a seal at the distal endthat is pierced by the vial piercing mechanism when the vial is insertedinto the housing.
 7. The apparatus of claim 6, further comprising: atube connected to the vial piercing mechanism, the tube configured tofluidly connect the vial piercing mechanism to the activation mechanism.8. The apparatus of claim 1, further comprising: a second threadedelement threadingly engaged with the first threaded element andpositioned on the longitudinal axis, the second threaded element and thefirst threaded element being at least partially positioned within thevial, the second threaded element and the first threaded element movingtelescopically relative to each other when the motor is activated. 9.The apparatus of claim 1, further comprising: a holding portion mountedto the housing and associated with the activation mechanism; and astructural element slidably mounted to the holding portion.
 10. Theapparatus of claim 9, wherein the structural element includes aprotrusion, the protrusion assisting in maintaining the button in theinitial position.
 11. The apparatus of claim 1, wherein the needle isoriented substantially perpendicular to the base plane.
 12. Theapparatus of claim 1, wherein the vial includes a protrusion protrudingfrom an inner surface and the first threaded element includes groove inan outer surface, the protrusion positioned in the groove to limitrotation of the first threaded element relative to the vial.